How the philosophy of Toyota, and simple feedback, communication and teamwork are transforming Bayers Berkeley biotech center.

Using Lean principles, one of Bayer Healthcare’s fermentation and media teams at the company’s biotech manufacturing center in Berkeley, California, is creating a culture of improved communication, training and shared process ownership.

Efforts began two years ago and have already brought about a significant decrease in batch record errors, improved overall staff proficiency by over 20%, boosted productivity by 50% and eliminated OSHA incidents, the last of which occurred in May 2007.

Pharmaceutical Manufacturing spoke with Saulye Sherrel, an émigrée from Kazakhstan with a degree in genetics who oversees production in two media and fermentation departments at Berkeley. She led this project at one department and is now taking it to the entire facility.

Saulye started at Bayer as a general manufacturing supervisor, becoming operational excellence Leader across multiple sites and the maintenance shop. Three years later, she joined Genentech to lead a Lean implementation which reportedly saved $12 million in six months. She returned to Bayer two years ago, as a manufacturing production manager. Very early in her career, she worked with BIOS, Inc., in Alma Ata, where her responsibilities included milking vipers and fractionating their venom using HPLC, and she also worked in the DNA section of the Las Vegas Police Department’s forensic lab.

We asked her about the Berkeley program, how it came to be and what results are being seen.

PhM: What led the company to change the way it was handling training, and to incorporate Lean?

S.S.: When I came to work for Bayer Healthcare, I took a production job because I felt that it would be a good challenge. After I’d been working at the site for a few quarters, the V.P introduced me to Lean. I had never heard about it before.

I then spent two to three years implementing different Lean tools at Bayer and Genentech. At this point, I began to realize that American businesses tend to focus too much on tools. We do not always understand the philosophical background behind these tools, and why Toyota developed them back in the 1940s.

In order for organizations to have a sustainable change of culture, an independent OpEx group cannot be pushing these efforts alone. Management must be involved in the concept and project.

PhM: So how did you get involved in this project at Bayer?

S.S.: Two years ago, while working as an OpEx manager at Genentech, I received a call from the same Bayer VP who had introduced me to Lean, who offered me a production manager position. My interview was largely about how I would roll out “The Toyota Way” at the site. I came in knowing that I would be piloting not only implementation of Lean tools but the Toyota Way. I’m not trying to follow the Toyota execution manual, but to see how Toyota’s tools can be used and tailored for what we do.

PhM: Is this program only going on in the cell culture operations, or is it a mandate tied into a larger corporate initiative?

S.S.: It started as a pilot, but the company has been watching results closely, and now the entire site will implement this approach. Right now, as a beginning step, everyone is getting to a very consistent implementation of standard work. Standard work is so often misunderstood. Some people just see it as a repeatable schedule to adhere to. I’d like to have them understand that it’s really about thinking more in the context of a process flow.

PhM: How did you get buy-in from the production floor?

S.S.: We did roll out some different Lean tools, but these efforts met with mixed response. If you just roll out tools, people don’t understand that the overall Lean philosophy should be long term and that it should be about continuous improvement and cultural change. You can get good results without taking the long-term view, but once the project champion leaves the site, results can’t be sustained.

“Human capital is variable and not always logical. You cant just take the tool without working on culture change.”

When the pilot began, I realized that, like most U.S. businesses, we were stuck in this very mature management model. Most of today’s American management concepts were developed by Henry Ford. We do not have anything new.

At the start, the organization was very hierarchical, very bureaucratic. Morning meetings with QA and engineering were led by management, and they were like ping pong matches. You’d sit in the ivory tower and discuss what happened on the floor, but you weren’t on the floor. Information took several days to filter up to management and the same amount of time to go from management to the plant floor.

I saw that people were siloed, not only in QA, engineering and manufacturing, but even within different shifts. We are one of the few biotech companies to use unionized labor at the facility, and, often, unionized labor is all about comfort. The result can often be firefighting, and when you see that, you know that people will be fundamentally unhappy.

We now have “safe” meetings where operators are free to bring up concerns without supervisors being present. I started asking people why they had such high batch record errors and so many OSHA citations.

I learned that they had no feedback on these errors. There was no democracy of information flow. Whatever improvements or issues that operators brought forth were either addressed very slowly or not at all.

I knew that I could get people to move from the old “I’m only responsible from 8 to 9 then all hell can break loose” approach to taking ownership by doing something very simple: asking them what hurt.

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